Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children

The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights.

Study Overview

• Status: Completed
• Conditions: Obstruction; Airway, With Asthma

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Children's Hospital Srebrnjak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young children admitted to the ward at the hospital due to acute lower airway obstruction/asthma exacerbation.

Description

Inclusion Criteria:

• Age 1-7
• Diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment

Exclusion Criteria:

• Need for an ICU treatment
• Bronchiolitis
• Pneumonia (not including viral infections)
• Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
• Implanted or external active medical devices

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Main group; Study has only one group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between clinical status and tidal breathing flow-volume (TBFV) curves	Assess the association between clinical status and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System	2-4 nights while at ward

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between lung function and tidal breathing flow-volume (TBFV) curves	Assess the association between lung function (spirometry or oscillometry) and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System	2-4 nights while at ward and 2 + 2 nights after discharge from hospital
Association between asthma control and tidal breathing flow-volume (TBFV) curves	Assess the association between asthma control (C-ACT questionnaire) and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System	2 + 2 nights after discharge from hospital

Collaborators and Investigators

• Sponsor: Revenio Research
• Collaborators: Children's Hospital Srebrnjak
• Investigators: Principal Investigator: Davor Plavec, MD, PhD, Children's Hospital Srebrnjak

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: VCS-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No